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Therapeutic Areas: Musculoskeletal | Neurology | Family Medicine | Orthopedics/Orthopedic Surgery
Disease Category: Lower Back Pain
Location: United States, GA
Clinical Trial Details
Research Study Summary
Low Back Pain
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy
Patient Inclusion Criteria:
- Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period.
- The low back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee); i.e., meeting Quebec Task Force Classification 1 or 2 19-21 (Section 14.1 Appendix A).
- Subjects must be:
- On ongoing opioid analgesic medication for at least 4 weeks prior to the screening visit (visit 1) and on a stable dose of opioid analgesic medication equivalent to 20 to 160 mg (inclusive) of morphine per day for the last 2 weeks prior to the screening visit (visit 1)
Patient Exclusion Criteria:
- Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation).
- Subjects with any contraindication to bisacodyl.
- Subjects with pain with distal radiation (below the knee) with or without neurologic signs, or presumptive or confirmed compression of a spinal nerve root (i.e., Quebec Task Force Classification 3 to 6 19-21; Section 14.1 Appendix A).
- Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia.
- Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uricacid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using NSAIDs or COX-2 inhibitors on a regular basis.
- Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions (in addition to those stated in Exclusion Criterion 3).
- Subjects who, in the opinion of the investigator, are exhibiting significant opioid withdrawal such that they should not be in the study.
- Subjects with evidence of significant structural abnormalities of the gastrointestinal tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, uncontrolled hypothyroidism).
- Subjects with a history of prior chronic constipation (including functional constipation or pelvic floor dyssynergy) that was present for more than three months and that was not related to opioid use.
- Subjects currently with clinically diagnosed diarrhea, defined as 3 stools/day that are loose or watery in nature within 2 weeks before visit 2.
- Subjects with irritable bowel syndrome (IBS) or inflammatory bowel disease (eg, ulcerative colitis, Crohn‘s disease).
- Subjects who had surgery that may affect gastrointestinal motility or gastrointestinal pain within 2 months prior to the start of the screening period, or who plan such surgery during the study.
- Subjects with a history of fecal incontinence.
- Subjects who require ongoing therapy with medications (other than opioids) that have contributed to the subjects‘ constipation in the judgment of the investigator.
- Subjects with hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Subjects who cannot or will not agree to completely stop all incoming opioid and nonopioid analgesic medications and other medications used for chronic pain (excluding herbal and neutraceutical medications as per the inclusion criteria 10). NSAIDs, aspirin, COX-2 inhibitors, and acetaminophen may be used intermittently during the course of the study for headache, fever, or acute pain other than low back pain; low dose aspirin for cardiovascular disease prophylaxis is allowed. Muscle relaxants may be used intermittently during the course of the study for treatment of acute muscle spasms. Medications such as antiepileptics and antidepressants may be continued only if not used for chronic pain.
- Subjects who cannot or will not agree to forego the following treatments during the study:
- nerve/plexus blocks or ablation, neurosurgical procedures for pain control, Botulinum toxin injections for pain control in the lumbar spine, steroid injections in the lumbar spine, or inhalation analgesia.
- The subject must not have had any of the following within the indicated time periods before screening (visit 1):
- nerve/plexus block within 4 weeks
- neuroablation within 6 months
- Botulinum toxin injection for pain control in the lumbar spine within 3 months
- steroid injections of the lumbar spine within 6 weeks or any intravenous or intramuscular steroid injections within 4 weeks
- Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit (visit 1) or planned during the study.
- Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.
- Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder (subjects with controlled depression or other psychiatric disorder must be on stable medication for at least 1 month prior to the screening visit [visit 1] to participate in the study).
- Subjects with an average QTcF of > 470 msec at the screening visit (visit 1) will be excluded.
- Subjects with evidence of impaired liver function upon entry into the study (laboratory test values = 3 times the upper limit of the laboratory reference (normal) range (ULN) for aspartate transaminase [AST/SGOT] or alanine transaminase [ALT/SGPT], or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator/medically qualified designee (must be MD or DO), liver function impairment to the extent that the subject should not participate in this study. Subjects with a total bilirubin level > 1.5 times the ULN due to Gilbert's syndrome are allowed in the study, but only if their AST/SGOT and ALT/SGPT values are in the laboratory reference (normal) range.
- Subjects with evidence of impaired kidney function upon entry into the study (i.e., serum creatinine = 2.5 mg/dL) should not participate in this study.
- Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit (visit 1).
- Patients taking moderate to strong CYP3A4 inhibitors if the dose has not been stable for at least 1 month (see 14.17 Appendix Q for a list of strong and moderate CYP3A4 inhibitors [as per FDA Guidance, 2006]).
- Patients for whom it is anticipated that therapy with a moderate to strong CYP3A4 inhibitor will be initiated during the study (see 14.17 Appendix Q for a list of strong and moderate CYP3A4 inhibitors [as per FDA Guidance, 2006]).
- Subjects with a history of alcohol, medication, or illicit drug abuse or addiction and/or history of opioid abuse or addiction at any time.
- Subjects with a positive result on urine drug testing for illicit drugs or non-prescribed opioids or with a positive breath alcohol result at visit 1 will be excluded.
- Subjects who have used any investigational medication within 30 days prior to the first dose of study medication.
- Subjects who had received a monoamine oxidase inhibitor within the last 14 days prior to the screening visit.
- Subjects with any condition in which opioids are contraindicated, such as severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, corpulmonale, severe bronchial asthma, or paralytic ileus.
- Subjects with increase of intracranial pressure and/or epilepsy (not including history of pediatric febrile seizures).
- Subjects with clinically significant cardiovascular disease or dysrhythmias.
- Subjects with biliary tract disease, hypothyroidism, adrenal cortical insufficiency, or any other medical condition that in the investigator‘s opinion is inadequately treated and precludes entry into the study.
- Subjects with an ongoing Workman‘s Compensation claim and/or litigation related to their low back pain.
- Subjects who, in the opinion of the Investigator, are unsuitable to participate in this study for any other reason.
- Subjects who have received study drug in a clinical study of OXN or ONU.
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Date Last Changed:
July 19, 2013
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